German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation
Recruiting now
Conditions studied: Alzheimer Disease
In brief
This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores.
Key facts
- Study ID
- NCT06313944
- Run by
- Heinrich-Heine University, Duesseldorf
- People needed
- 100
- Starts
- 2025-08-06
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-07-16
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- i. Age = 18 to 85 ii. N>=100, clinical Alzheimer's syndrome, defined by a gradually progressive change in memory function (for severity using the MMSE as a screening tool) and impairment of activities of daily living for more than six months iii. MRI scan, in vivo evidence from CSF and/or PET using the NIA-AA criteria, which categorize the underlying pathological processes based on biomarkers, should be added if possible, but are optional. These biomarkers are categorized as ß-amyloid deposition, pathological tau and neurodegeneration [AT(N)], which can be detected on imaging and in biofluids. If possible, patients with Alzheimer's disease (AD) or Alzheimer's continuum should be included.
- iv. TPS treatment in a center of a neurological or psychiatric specialist and performed under supervision of a specialist
You may not qualify if…
- i. Relevant intracerebral pathologies not related to Alzheimer's disease, such as vascular encephalopathy Fazekas grade 3, tumors, vascular malformations, pregnancy, metal implants, CAA according to Boston criteria, Z.n. or during antibody therapy ii. Blood coagulation disorders or oral anticoagulation iii. Epilepsy iv. Medical conditions leading to non-compliance with the protocol
Where it is running
- Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie — Potsdam, Brandenburg, Germany (enrolling)
- Evangelische Krankenhausstiftung Oldenburg - Universitätsklinik für Neurologie — Oldenburg, Lower Saxony, Germany (enrolling)
- Praxis Dr. Schwarz — Ulm, Germany (enrolling)
- Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen — Bonn, North Rhine-Westphalia, Germany
- Neurologische Praxis Prof. Wojtecki — Neuss, North Rhine-Westphalia, Germany
- Hospital zum Heiligen Geist GmbH & Co KG Klinik für Neurologie und Neurorehabilitation — Kempen, Germany
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.